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Huestis Medical Collimator

FDA UDI

Class II (US FDA UDI)

by Huestis Machine Corp.

Identity

Trade Name
Huestis Medical Collimator FDA UDI
Generic Name
Automatic-aperture-control diagnostic x-ray system collimator FDA UDI
Device Name
150PBL/SC Thin Mirror Collimator, ( Huestis Part # CM-3201-201 ) FDA UDI
Model / Reference
CM-3201-101 FDA UDI
Description
150PBL/SC Thin Mirror Collimator, ( Huestis Part # CM-3201-201 ) FDA UDI

Identifiers

Primary DI / UDI-DI
00850077007149 FDA UDI
510(k) Number
K972966 FDA UDI
FDA Product Code
IZX FDA UDI
GMDN Term
Automatic-aperture-control diagnostic x-ray system collimator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1610 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Automatic-aperture-control diagnostic x-ray system collimator

Huestis Medical Collimator by Huestis Machine Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Automatic-aperture-control diagnostic x-ray system collimator.

Cleared under the same submission

K972966 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Huestis Machine Corp.

Sources (1)

  • FDA UDI a0c70a49-b531-45aa-949c-40e9c8af6eeb 34 fields · synced Jun 6, 2026